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Administrative data

Description of key information

Skin irritation/corrosion:

One in vivo study is available, which was conducted according to OECD 404, exposure for 4 hours and the test substance is not irritant to the skin.

Eye irritation:

One in vivo study is available, which was conducted according to OECD 405, and the test substance is not irritant to the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1994-01-10 to 1994-01-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Lot No.: Batch 9
Purity: Not specified
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler; Offenbach / Main, Frg
- Age at study initiation: young adult animals
- Weight at study initiation: 3.15-3.49 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2, no bedding in the cages; sawdust in the waste trays
- Diet (e.g. ad libitum): about 130 g per animal per day
- Water (e.g. ad libitum): about 250 mL tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light):12 h/12 h
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): Untreated skin sites of the same animal
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
- Weight determination: shortly before application of the test substance.
- Route of application: the test substance was applied in a single dose to the intact untreated skin. The test patch was secured in position with a semiocclusive dressing. The test substance was removed at the end of the exposure period with Lutrol(R) and Lutrol(R)/water (1:1)
- Application volume: The test patch (2 .5 cm x 2 .5 cm) was covered with a dose of 0 .5 g of the semi-solid test substance and has been moistened with aqua bidest.
- Application site: upper third of the back or flanks
- Readings: 1 h, 24 h, 48 h and 72 h after removal of the patch .
- General observations: A check was made twice each workday and once on Saturdays, Sundays and on public holidays for general observations and for any dead or moribund animals.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No skin reaction could be observed in all animals

Animal No.

Time after

application

 

Erythema

 

Edema

1

1 hour

0

0

 

24 hours

0

0

 

48 hours

0

0

 

72 hours

0

0

 

2

1 hour

0

0

 

24 hours

0

0

 

48 hours

0

0

 

72 hours

0

0

 

3

1 hour

0

0

 

24 hours

0

0

 

48 hours

0

0

 

72 hours

0

0

 

Interpretation of results:
GHS criteria not met
Conclusions:
The test item does not give indication of an irritant property to the skin.
Executive summary:

The potential of test item to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 g of the test substance to the intact skin of 3 white Vienna rabbits for 4 hours under semiocclusive dressing based on OECD404.

As no skin reaction could be observed in all animals, the study was terminated 72 hours after removal of the patches.

Under the test conditions chosen and considering the described findings the test item does not give indication of an irritant property to the skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1994-01-17 to 1994-01-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Lot No.: Batch 9
Purity: Not specified
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler; Offenbach / Main, Frg
- Age at study initiation: young adult animals
- Weight at study initiation: 3.44-3.95 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2, no bedding in the cages; sawdust in the waste trays
- Diet (e.g. ad libitum): about 130 g per animal per day
- Water (e.g. ad libitum): about 250 mL tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL bulk volume (about 20 mg)
Duration of treatment / exposure:
72 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
- Weight determination: shortly before application of the test substance.
- Route of application: single application to the conjunctival sac of the right eyelid; the substance was not washed out.
- Readings: 1 h, 24 h, 48 h and 72 h after application.
- General observations: a check was made twice each workday and once on Saturdays, Sundays and on public holidays for general observations and for any dead or moribund animals
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
The findings were reversible in all animals within 24 hours after application.

Animal No.

Time after

application

Cornea opacity

 

 

Iris

Conjunctivae

Redness

Chemosis

1

1 hour

0

0

2

0

24 hours

0

0

0

0

48 hours

0

0

0

0

72 hours

0

0

0

0

2

1 hour

0

0

1

0

24 hours

0

0

0

0

48 hours

0

0

0

0

72 hours

0

0

0

0

3

1 hour

0

0

1

0

24 hours

0

0

0

0

48 hours

0

0

0

0

72 hours

0

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions chosen and considering the described findings the test item does not give indication of an irritant property to the eye.
Executive summary:

The potential of test item to cause damage to the conjunctiva, iris or cornea was assessed in 3 white vienna rabbits in compliance with OECD405, subjected to a single ocular application of about 20 mg of the test substance on day 0.

The average score (24 to 72 hours) for irritation was calculated to be 0 .0 for corneal opacity, iris, conjunctivae redness and for chemosis .

The findings were reversible in all animals within 24 hours after application, thus the study was terminated after 72 hours.

Under the test conditions chosen and considering the described findings the test item does not give indication of an irritant property to the eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification

Skin irritation/corrosion:

Mean erythema score of 24, 48 and 72h: 0; Mean edema score of 24, 48 and 72h: 0

According to Regulation (EC) No 1272/2008, table 3.2.2, this substance should not be classified for this endpoint.

 

Serious eye damage/eye irritation:

Mean score of 24, 48 and 72h: cornea opacity 0; iris: 0; conjunctivae: 0; chemosis: 0

According to Regulation (EC) No 1272/2008, table 3.3.1 and 3.3.2, this substance should not be classified for this endpoint.

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